Evaluation of Early Percutaneous Tracheostomy in Patients Undergoing Cardiovascular Surgery and Requiring Prolonged Mechanical Ventilation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.
研究概览
简要总结
This is a phase III clinical trial comparing early tracheostomy (day 4) versus prolonged endotracheal intubation in ICU patients needing prolonged ventilatory support after cardiovascular surgery.
详细描述
Background: Prolonged mechanical ventilation (MV> 7 days) is required in less than 10% of patients after cardiovascular surgery but it is associated with high morbidity and mortality.
Several studies conducted in critically ill patients suggested that early percutaneous tracheotomy compared with delayed tracheotomy decreases the length of ventilator dependence and improves outcome. To date, no randomized trial has tested these possible benefits in critically ill patients after cardiac surgery.
Study objectives: A randomized trial has been designed to determine whether early tracheostomy (day 4 after cardiac surgery) in patients still on MV would reduce the number of days under MV, measured by the evaluation of ventilator-free days (VFDs). Secondary objectives are the reduction of mortality, reduction of ICU and hospital length of stay. Evaluation of organ failure evolution, infectious complications, sedation needs, patient comfort and outcome at 3 months will be also considered.
Study hypothesis: The trial will be consider positive if early tracheotomy increases the number VFDs of at least 7 days (mean) evaluated on day 60 after randomisation.
Methods :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18 years of age or older
- •Have undergone cardiovascular surgery
- •Are still on invasive mechanical ventilation on day 4 after surgery
- •Have failed the screening test or the spontaneous breathing trial
- •Have signed the informed consent (patient or legal representative)
排除标准
- •Age less than18
- •Pregnant woman
- •Intubation more than 48 hours before cardiovascular surgery
- •More than 5 days on mechanical ventilation after cardiac surgery
- •Artificial heart implantation
- •Concomitant neck surgery (carotid)
- •Previously tracheostomized
- •Major hemorrhagic risk
- •Persistence of platelet count less than 50.000/mm3 after platelet transfusion
- •Prothrombin time less than 30% despite coagulation factors administration
- •Clinical evidence of ongoing infection at the proposed tracheotomy site
- •Anatomical deformity of the neck making risky a tracheostomy
- •Probability of dying the day of randomization defined by SAPSII more than 80
- •Irreversible neurological lesions
- •Decision of care limitation
- •Prior inclusion in a trial with morbidity-mortality as main judgement criteria
- •Previous enrollment in this trial
- •Consent refusal
结局指标
主要结局
Number of ventilator-free days defined as the number of days between successful weaning from MV and day 60 after study enrolment.
时间窗: between successful weaning from MV and day 60 after study enrolment.
VFDs = 0 if the patient dies before 60days.
时间窗: before 60 days
VFDs= (60- X) : if the patient is successfully weaned from MV within 60 days, where X is the number of days spent receiving MV
时间窗: during 60 days
VFDs = 0: if the patient requires MV for 60 days or more
时间窗: during 60 days and after
The trial will be considered positive if early tracheostomy increases the number VFDs of at least 7 days (mean)
时间窗: at 7 days
次要结局
- Other outcomes will be compared between the two arms:(during the trial)
- Mortality rate (day 60, in-ICU, in-hospital)(during the 60 days)
- ICU length of stay(during the trial)
- Hospital length of stay(during the trial)
- Duration of MV in survivors(during the trial)
- Organ failure evolution(during the trial)
- Infectious complications(during the trial)
- Early laryngeal and tracheal complications(during the trial)
- Sedation needs(during the trial)
- Patient comfort(during the trial)
- Outcome on day 90(to 90 days)